Quality control and performance of HIV rapid tests in a microbicide clinical trial in rural KwaZulu-Natal.

BACKGROUND: Quality control (QC) and evaluation of HIV rapid test procedures are an important aspect of HIV prevention trials. We describe QC and performance of two rapid tests, Determine™ and Uni-Gold™ used in a microbicide clinical trial in rural KwaZulu-Natal, South Africa. METHODS/RESULTS: Internal QC of both HIV rapid tests was conducted at the trial site using a Uni-Gold control kit (Uni-Gold™Recombigen® HIV). Both assays produced the expected results for a total of 4637 QC tests. Study participants were tested for HIV at screening and, if enrolled, at regular time points throughout the study. Positive or discordant results were confirmed by a double HIV immunoassay testing strategy at a local laboratory. Overall, 15292 HIV rapid test were performed. Sensitivity and specificity of Determine was 98.95% (95% CI: 97.72-99.61) and 99.83% (95% CI: 99.70-99.91) respectively [positive predictive value (PPV) 97.91% (95% CI: 96.38-98.92)], for Uni-Gold it was 99.30% (95% CI: 98.21-99.81) and 99.96% (95% CI: 99.88-99.99) respectively [PPV 99.47% (95% CI: 98.46-99.89)]. CONCLUSIONS: The results suggest that a Uni-Gold control kit can be used for internal QC of both Uni-Gold and the HIV-1 component of the Determine rapid tests. Both rapid tests performed proficiently in the trial population

Communication About Microbicide Use Between Couples in KwaZulu-Natal, South Africa

The ways in which couples communicate about microbicides is likely to influence microbicide uptake and usage. We collected quantitative data about whether women in a microbicide trial discussed microbicides with their partners and explored communication about microbicides during 79 in-depth-interviews with women enrolled in the trial and 17 focus-group discussions with community members. After 4 weeks in the trial, 60 % of 1092 women had discussed microbicides with their partners; in multivariate analysis, this was associated with younger age, clinic of enrolment and not living in households that owned cattle. After 52 weeks, 84 % of women had discussed microbicides; in multivariate analysis, this was associated with not living in households that owned cattle, not living in a household that relied on the cheapest water source, allocation to 0.5 % PRO2000 gel and consistent gel adherence. Qualitative findings highlighted that women in committed relationships were expected to discuss microbicides with their partners and preferred to use microbicides with their partner's knowledge. Women had different reasons for, and ways of, discussing microbicides and these were influenced by the couple's decision-making roles. Although there was tolerance for the use of microbicides without a partner's knowledge, the women who used microbicides secretly appeared to be women who were least able to discuss microbicides. In KwaZulu-Natal, socio-cultural norms informing sexual communication are amenable to microbicide introduction

The implications of post-coital intravaginal cleansing for the introduction of vaginal microbicides in South Africa.

Post-coital intravaginal cleansing (IVC) could counteract the protective effect of a vaginal microbicide. IVC less than 1 h after sex is discouraged in most microbicide trials. During a microbicide trial in KwaZulu-Natal, we collected quantitative data on post-coital IVC. We discussed IVC during in-depth-interviews (IDIs) and focus-group discussions (FGDs) with women enrolled in the trial, and during FGDs with community members. Nearly one-third (336/1,143) of women reported IVC less than an hour after sex. In multivariate analysis, post-coital IVC was associated with younger age, larger household size, greater sexual activity, consistent gel use, and clinic of enrolment. During IDIs and FGDs, respondents described post-coital IVC as a common hygiene practice motivated by the need to remove semen, vaginal fluids and sweat, although this practice may be amenable to change in the context of microbicide use. We need to consider strategies for influencing post-coital IVC practices in future microbicide trials and delivery programmes

Re-framing microbicide acceptability: findings from the MDP301 trial.

Microbicides are most usually conceptualised within a disease prevention framework and studies usually define acceptability in terms of product characteristics, willingness to use and risk reduction. This starting point has led to assumptions about microbicides which, rather than being challenged by empirical studies, have tended to foreclose the data and subsequent conceptual models. Few studies take an emic ('insider') perspective or attempt to understand how microbicides fit into the broader context of women's and men's everyday lives. As part of the integrated social science component of the MDP301 Phase III microbicide trial, in-depth interviews were conducted with female trial participants in South Africa, Zambia, Tanzania and Uganda. Women's experiences of the gel challenge several assumptions that have commonly been reiterated about microbicides. Our analysis suggests that current definitions and conceptual frameworks do not adequately account for the range of meanings that women attribute to gel. Even within the context of a clinical trial, it is possible to obtain a richer, ethnographic and cross-cultural concept of acceptability based on women's practice and emic interpretations. We now need to move beyond limited notions of acceptability and consider how microbicides fit into a more holistic picture of women's and men's sexuality and sexual health